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Model Number IPN923527 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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The report states that "the user inserted the catheter at the groin.However, probably because the iliac artery was severely calcified and bent, the catheter kinked.The user removed it and confirmed the tip kinked.Then the user inserted another catheter of the same lot at the same insertion site, by which completed the procedure without problem.No harm to the patient was reported.The user flushed the catheter, but did not perform the inflation test before use".No report of delay in therapy.
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Manufacturer Narrative
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Qn#(b)(4).The reported complaint of catheter kinked/bent in use is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.The reported complaint will be monitored for any developing trends.Additionally, unrelated to the reported complaint, it was stated in the event details, that the user "did not perform the inflation test before use".As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.
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Event Description
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The report states that "the user inserted the catheter at the groin.However, probably because the iliac artery was severely calcified and bent, the catheter kinked.The user removed it and confirmed the tip kinked.Then the user inserted another catheter of the same lot at the same insertion site, by which completed the procedure without problem.No harm to the patient was reported.The user flushed the catheter but did not perform the inflation test before use".No report of delay in therapy.
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Search Alerts/Recalls
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